Metastatic Breast CancerPhase 2NCT05769010
Study of SHR-A1811 in HER2-expression Advanced Breast Cancer With Brain Metastases
A Phase 2 study testing SHR-A1811, Pyrotinib and Bevacizumab in people with Metastatic Breast Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
This study aimed to evaluate the use of SHR-A1811 in HER2-expression Advanced Breast Cancer patients with brain metastases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- SHR-A1811, Pyrotinib and Bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2023to 30 Jun 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females and males ≥18 yrs old;
- Pathologically confirmed HER2-positive or HER2-low advanced breast cancer;
- At least one measurable intracranial lesion according to RANO-BM criteria, which had not received local treatment;
- Without prior cranial radiation and had no indication for immediate local treatment or refuse to local treatment;
- More than 2 weeks from last systemic treatment; patients with new brain lesions after craniocerebral surgery were admitted if no radiotherapy was performed. Patients with HER2-Low disease must not have systemic treatment for brain metastases.
- Prior HER2-target treatment, endocrine therapy and chemotherapy was allowed;
- Life expectancy is not less than 6 months.
- Adequate function of major organs.
Who cannot join
- Leptomeningeal involvement;
- CNS complications requiring emergency neurosurgical intervention (e.g. excision, shunt tube placement);or uncontrolled symptomatic brain metastases;
- Previous treatment with trastuzumab deruxtecan (DS-8201a) or any other antibody drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase 1 inhibitor;
- Patients who had progressed on previous HER2 tyrosine kinase inhibitor therapy were excluded from Arm 2, and those who had progressed on previous bevacizumab therapy were excluded from Arm 3 and Arm 5 ,and Arm 6 excludes patients who have progressed on prior PD-1 or PD-L1 therapy;
- No concurrent antitumor therapy for metastatic cancer other than the study treatment;
- Antitumor radiotherapy, chemotherapy, surgery, targeted therapy, or immunotherapy within 2 weeks or endocrine therapy within 1 week prior to enrolment;
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- Participated in other drug clinical trials within 4 weeks before admission;
- History of clinically significant lung disease；
- Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years.
- According to the judgement of the researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of research (including, but not limited to, severe hypertension, severe diabetes, active infections, etc.).
- Any other conditions that researchers believe that patients are unsuitable for this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Min Yan, Professor, +86 15713857388, ym200678@126.com
About this study
Official title: A Prospective, Open-label Explorative Study of SHR-A1811 in HER2-expression Advanced Breast Cancer With Brain Metastases
This study aimed to evaluate the use of SHR-A1811 in HER2-expression Advanced Breast Cancer patients with brain metastases.
- Conditions
- Metastatic Breast Cancer
- Being tested
- SHR-A1811, Pyrotinib, Bevacizumab, Adebelizumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1811Drug
SHR-A1811: intravenous
PyrotinibDrug
Pyrotinib: oral
BevacizumabDrug
Bevacizumab: intravenous
AdebelizumabDrug
Adebelizumab: intravenous
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | HER2-positive: SHR-A1811 Receives: Drug: SHR-A1811 |
| Arm 2 | Experimental | HER2-positive: SHR-A1811 and pyrotinib Receives: Drug: SHR-A1811; Drug: Pyrotinib |
| Arm 3 | Experimental | HER2-positive: SHR-A1811 and bevacizumab Receives: Drug: SHR-A1811; Drug: Bevacizumab |
| Arm 4 | Experimental | HER2-low: SHR-A1811 Receives: Drug: SHR-A1811 |
| Arm 5 | Experimental | HER2-low: SHR-A1811 and bevacizumab Receives: Drug: SHR-A1811; Drug: Bevacizumab |
| Arm 6 | Experimental | HER2-low: SHR-A1811 and Adebelizumab Receives: Drug: SHR-A1811; Drug: Adebelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
CNS-ORR by investigator
CNS-ORR was defined as percentage of participants with CNS response assessed by the investigator according to RANO-BM criteria
Measured: 2 months
Secondary outcomes (3)
ORR by investigator using RECIST Guideline (Version 1.1)
ORR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR assessed by the investigator according to RECIST version 1.1
Measured: 2 months
PFS
PFS was defined as the time from first dose to first documented disease progression (PD) or death from any cause, whichever occurred first
Measured: up to 1.5 years
Adverse events
Proportion of participants experienced adverse events during the study period
Measured: up to 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start31 Mar 2023
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Min Yan, MD, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769010
- Sponsor's protocol ID
- HNCH-MBC12
- Other IDs
- HNCH-MBC12-BM04
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2023
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label Explorative Study of SHR-A1811 in HER2-expression Advanced Breast Cancer With Brain Metastases
- ClinicalTrials.gov ID
- NCT05769010
- Acronym / sponsor ID
- HNCH-MBC12
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to evaluate the use of SHR-A1811 in HER2-expression Advanced Breast Cancer patients with brain metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: SHR-A1811HER2-positive: SHR-A1811 |
| Arm 2 | Experimental | Drug: SHR-A1811, Drug: PyrotinibHER2-positive: SHR-A1811 and pyrotinib |
| Arm 3 | Experimental | Drug: SHR-A1811, Drug: BevacizumabHER2-positive: SHR-A1811 and bevacizumab |
| Arm 4 | Experimental | Drug: SHR-A1811HER2-low: SHR-A1811 |
| Arm 5 | Experimental | Drug: SHR-A1811, Drug: BevacizumabHER2-low: SHR-A1811 and bevacizumab |
| Arm 6 | Experimental | Drug: SHR-A1811, Drug: AdebelizumabHER2-low: SHR-A1811 and Adebelizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Females and males ≥18 yrs old;
- Pathologically confirmed HER2-positive or HER2-low advanced breast cancer;
- At least one measurable intracranial lesion according to RANO-BM criteria, which had not received local treatment;
- Without prior cranial radiation and had no indication for immediate local treatment or refuse to local treatment;
- More than 2 weeks from last systemic treatment; patients with new brain lesions after craniocerebral surgery were admitted if no radiotherapy was performed. Patients with HER2-Low disease must not have systemic treatment for brain metastases.
Key exclusion criteria (11 listed)
- Leptomeningeal involvement;
- CNS complications requiring emergency neurosurgical intervention (e.g. excision, shunt tube placement);or uncontrolled symptomatic brain metastases;
- Previous treatment with trastuzumab deruxtecan (DS-8201a) or any other antibody drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase 1 inhibitor;
- Patients who had progressed on previous HER2 tyrosine kinase inhibitor therapy were excluded from Arm 2, and those who had progressed on previous bevacizumab therapy were excluded from Arm 3 and Arm 5 ,and Arm 6 excludes patients who have progressed on prior PD-1 or PD-L1 therapy;
- No concurrent antitumor therapy for metastatic cancer other than the study treatment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-A1811SHR-A1811: intravenous | Drug | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5, Arm 6 |
| PyrotinibPyrotinib: oral | Drug | Arm 2 |
| BevacizumabBevacizumab: intravenous | Drug | Arm 3, Arm 5 |
| AdebelizumabAdebelizumab: intravenous | Drug | Arm 6 |
Primary outcome
CNS-ORR by investigator
Time frame: 2 months
CNS-ORR was defined as percentage of participants with CNS response assessed by the investigator according to RANO-BM criteria
3 secondary outcomes
ORR by investigator using RECIST Guideline (Version 1.1)
Time frame: 2 months
PFS
Time frame: up to 1.5 years
Adverse events
Time frame: up to 1.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-A1811, Pyrotinib and Bevacizumab in people with Metastatic Breast Cancer, run by Henan Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Yan, Professor (+86 15713857388, ym200678@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CNS-ORR by investigator (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.